Trial Outcomes & Findings for Evaluation of Tobacco Treatment Strategies for Inpatient Psychiatry (NCT NCT00968513)

NCT ID: NCT00968513

Last Updated: 2025-06-11

Results Overview

Number of Participants who Quit Smoking at 3, 6, 12, and 18 Months

Recruitment status

COMPLETED

Study phase

Target enrollment

956 participants

Primary outcome timeframe

3, 6, 12, and 18 Month Follow-up

Results posted on

2025-06-11

Participant Flow

Participant milestones

Participant milestones
Measure	Usual Care Usual Care: brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization	Brief Treatment Brief Intervention: adds a stage-based manual, computer-delivered stage-tailored individualized feedback and brief cessation counseling sessions during hospitalization and repeated at months 3 and 6, and access to 12 weeks of nicotine replacement following hospitalization	Extended Treatment Extended Treatment: builds upon our current brief treatment and provides 12 additional weeks of nicotine replacement (24 weeks total) with individualized, counselor-delivered motivational and manualized cognitive behavioral cessation treatment.
Overall Study STARTED	132	416	408
Overall Study COMPLETED	128	406	393
Overall Study NOT COMPLETED	4	10	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Usual Care Usual Care: brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization	Brief Treatment Brief Intervention: adds a stage-based manual, computer-delivered stage-tailored individualized feedback and brief cessation counseling sessions during hospitalization and repeated at months 3 and 6, and access to 12 weeks of nicotine replacement following hospitalization	Extended Treatment Extended Treatment: builds upon our current brief treatment and provides 12 additional weeks of nicotine replacement (24 weeks total) with individualized, counselor-delivered motivational and manualized cognitive behavioral cessation treatment.
Overall Study Death	4	10	15

Baseline Characteristics

Evaluation of Tobacco Treatment Strategies for Inpatient Psychiatry

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care n=132 Participants Usual Care: brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization	Brief Treatment n=416 Participants Brief Intervention: adds a stage-based manual, computer-delivered stage-tailored individualized feedback and brief cessation counseling sessions during hospitalization and repeated at months 3 and 6, and access to 12 weeks of nicotine replacement following hospitalization	Extended Treatment n=408 Participants Extended Treatment: builds upon our current brief treatment and provides 12 additional weeks of nicotine replacement (24 weeks total) with individualized, counselor-delivered motivational and manualized cognitive behavioral cessation treatment.	Total n=956 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	130 Participants n=5 Participants	404 Participants n=7 Participants	397 Participants n=5 Participants	931 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	12 Participants n=7 Participants	11 Participants n=5 Participants	25 Participants n=4 Participants
Age, Continuous	38 years n=5 Participants	39 years n=7 Participants	38 years n=5 Participants	39 years n=4 Participants
Sex/Gender, Customized Female	63 Participants n=5 Participants	202 Participants n=7 Participants	194 Participants n=5 Participants	459 Participants n=4 Participants
Sex/Gender, Customized Male	67 Participants n=5 Participants	209 Participants n=7 Participants	211 Participants n=5 Participants	487 Participants n=4 Participants
Sex/Gender, Customized Transgender	2 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Region of Enrollment United States	132 participants n=5 Participants	416 participants n=7 Participants	408 participants n=5 Participants	956 participants n=4 Participants

PRIMARY outcome

Timeframe: 3, 6, 12, and 18 Month Follow-up

Number of Participants who Quit Smoking at 3, 6, 12, and 18 Months

Outcome measures

Outcome measures
Measure	Usual Care n=132 Participants Usual Care: brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization	Brief Treatment n=416 Participants Brief Intervention: adds a stage-based manual, computer-delivered stage-tailored individualized feedback and brief cessation counseling sessions during hospitalization and repeated at months 3 and 6, and access to 12 weeks of nicotine replacement following hospitalization	Extended Treatment n=408 Participants Extended Treatment: builds upon our current brief treatment and provides 12 additional weeks of nicotine replacement (24 weeks total) with individualized, counselor-delivered motivational and manualized cognitive behavioral cessation treatment.
Number of Participants Who Quit Smoking at 3, 6, 12, and 18 Months 3 month	13 Participants	70 Participants	63 Participants
Number of Participants Who Quit Smoking at 3, 6, 12, and 18 Months 6 month	15 Participants	75 Participants	78 Participants
Number of Participants Who Quit Smoking at 3, 6, 12, and 18 Months 12 month	21 Participants	78 Participants	74 Participants
Number of Participants Who Quit Smoking at 3, 6, 12, and 18 Months 18 month	17 Participants	80 Participants	82 Participants

PRIMARY outcome

Timeframe: baseline, 3, 6, 12, and 18 months

Population: Missing values at each timepoint per group were excluded from analyses.

Changes from one assessment point to the next in a Likert scale (1 to 10) measure of desire to quit smoking. 10 = strongest desire to quit.

Outcome measures

Outcome measures
Measure	Usual Care n=132 Participants Usual Care: brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization	Brief Treatment n=416 Participants Brief Intervention: adds a stage-based manual, computer-delivered stage-tailored individualized feedback and brief cessation counseling sessions during hospitalization and repeated at months 3 and 6, and access to 12 weeks of nicotine replacement following hospitalization	Extended Treatment n=408 Participants Extended Treatment: builds upon our current brief treatment and provides 12 additional weeks of nicotine replacement (24 weeks total) with individualized, counselor-delivered motivational and manualized cognitive behavioral cessation treatment.
Commitment to Abstinence Baseline	5.83 score on a scale Interval 1.0 to 10.0	6.20 score on a scale Interval 1.0 to 10.0	5.85 score on a scale Interval 1.0 to 10.0
Commitment to Abstinence 3 month	6.27 score on a scale Interval 1.0 to 10.0	7.44 score on a scale Interval 1.0 to 10.0	7.09 score on a scale Interval 1.0 to 10.0
Commitment to Abstinence 6 month	6.65 score on a scale Interval 1.0 to 10.0	7.22 score on a scale Interval 1.0 to 10.0	7.21 score on a scale Interval 1.0 to 10.0
Commitment to Abstinence 12 month	7.06 score on a scale Interval 1.0 to 10.0	7.44 score on a scale Interval 1.0 to 10.0	7.33 score on a scale Interval 1.0 to 10.0
Commitment to Abstinence 18 month	7.05 score on a scale Interval 1.0 to 10.0	7.47 score on a scale Interval 1.0 to 10.0	7.37 score on a scale Interval 1.0 to 10.0

PRIMARY outcome

Timeframe: 3, 6, 12, and 18 months follow-up

Number of participants with quit attempts lasting 24 hours or more at each follow up timepoint.

Outcome measures

Outcome measures
Measure	Usual Care n=132 Participants Usual Care: brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization	Brief Treatment n=416 Participants Brief Intervention: adds a stage-based manual, computer-delivered stage-tailored individualized feedback and brief cessation counseling sessions during hospitalization and repeated at months 3 and 6, and access to 12 weeks of nicotine replacement following hospitalization	Extended Treatment n=408 Participants Extended Treatment: builds upon our current brief treatment and provides 12 additional weeks of nicotine replacement (24 weeks total) with individualized, counselor-delivered motivational and manualized cognitive behavioral cessation treatment.
Number of Participants With Quit Attempts Lasting 24 Hours or More 3 month	42 participants	181 participants	162 participants
Number of Participants With Quit Attempts Lasting 24 Hours or More 6 month	40 participants	169 participants	149 participants
Number of Participants With Quit Attempts Lasting 24 Hours or More 12 month	47 participants	156 participants	170 participants
Number of Participants With Quit Attempts Lasting 24 Hours or More 18 month	47 participants	183 participants	165 participants

Adverse Events

Usual Care

Serious events: 105 serious events

Other events: 17 other events

Deaths: 0 deaths

Brief Treatment

Serious events: 308 serious events

Other events: 120 other events

Deaths: 0 deaths

Extended Treatment

Serious events: 310 serious events

Other events: 126 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Judith Prochaska

Stanford University

Phone: 6507243608

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Usual Care n=132 participants at risk Usual Care: brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization	Brief Treatment n=416 participants at risk Brief Intervention: adds a stage-based manual, computer-delivered stage-tailored individualized feedback and brief cessation counseling sessions during hospitalization and repeated at months 3 and 6, and access to 12 weeks of nicotine replacement following hospitalization	Extended Treatment n=408 participants at risk Extended Treatment: builds upon our current brief treatment and provides 12 additional weeks of nicotine replacement (24 weeks total) with individualized, counselor-delivered motivational and manualized cognitive behavioral cessation treatment.
Gastrointestinal disorders stomach pain, cramps, issues, infections, ulcer	1.5% 2/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	2.2% 9/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	2.2% 9/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Infections and infestations Stomach infection/flu	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.49% 2/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
General disorders Fever	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.48% 2/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.74% 3/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Social circumstances Frostbite	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.25% 1/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Social circumstances Heat exhaustion.	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.24% 1/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Social circumstances Hypothermia	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.24% 1/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
General disorders Increased temperature	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.25% 1/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
General disorders Unknown medical visit	2.3% 3/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	2.6% 11/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	2.2% 9/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Psychiatric disorders Unknown psychiatric visit	2.3% 3/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	3.6% 15/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	3.4% 14/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Surgical and medical procedures Vaccinations	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.24% 1/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.25% 1/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Injury, poisoning and procedural complications Vehicular injury	2.3% 3/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	2.4% 10/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	2.2% 9/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Musculoskeletal and connective tissue disorders Torn ligament	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.24% 1/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.25% 1/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Respiratory, thoracic and mediastinal disorders nasal congestion	0.76% 1/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Respiratory, thoracic and mediastinal disorders Pneumonia	2.3% 3/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	2.4% 10/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.98% 4/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Respiratory, thoracic and mediastinal disorders Shortness of breath	0.76% 1/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	1.7% 7/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.98% 4/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Infections and infestations Venereal disease	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.25% 1/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Injury, poisoning and procedural complications Rib pain/injuries	0.76% 1/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.24% 1/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.49% 2/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Nervous system disorders Seizure	2.3% 3/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	1.9% 8/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	1.5% 6/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Social circumstances Sexual assault/rape	1.5% 2/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.48% 2/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.25% 1/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Injury, poisoning and procedural complications Shoulder injury/pain	1.5% 2/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	1.4% 6/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.98% 4/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
General disorders Sleep problems	1.5% 2/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.72% 3/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.25% 1/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Psychiatric disorders Placed on a 5150	16.7% 22/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	18.3% 76/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	17.9% 73/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Psychiatric disorders Placed on a 5250	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.24% 1/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Social circumstances Accused of assault	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.25% 1/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Injury, poisoning and procedural complications Ankle pain/injuries	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	1.4% 6/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.98% 4/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Infections and infestations Ankle infection	0.76% 1/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Injury, poisoning and procedural complications Arm pain/injuries	0.76% 1/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	1.7% 7/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	1.2% 5/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Infections and infestations Arm infection	0.76% 1/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Injury, poisoning and procedural complications Injuries and treatment from assault excluding sexual assault	1.5% 2/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	1.7% 7/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	1.5% 6/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Immune system disorders Autoimmune disease	0.76% 1/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.48% 2/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Social circumstances AWOL and re-admission	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.24% 1/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Injury, poisoning and procedural complications Back pain/discomfort/injury	2.3% 3/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	2.4% 10/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	2.0% 8/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Blood and lymphatic system disorders Blood clot	0.76% 1/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.24% 1/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.49% 2/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Surgical and medical procedures Blood transfusion	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.24% 1/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Surgical and medical procedures Bloodwork	0.76% 1/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
General disorders Hemoptysis	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.25% 1/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Blood and lymphatic system disorders Hyperglycemia	0.76% 1/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.72% 3/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.25% 1/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Blood and lymphatic system disorders Hypertension	0.76% 1/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.48% 2/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.49% 2/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Blood and lymphatic system disorders Hypoglycemia	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.24% 1/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.25% 1/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Blood and lymphatic system disorders Hypotension	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.24% 1/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.49% 2/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.

Other adverse events
Measure	Usual Care n=132 participants at risk Usual Care: brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization	Brief Treatment n=416 participants at risk Brief Intervention: adds a stage-based manual, computer-delivered stage-tailored individualized feedback and brief cessation counseling sessions during hospitalization and repeated at months 3 and 6, and access to 12 weeks of nicotine replacement following hospitalization	Extended Treatment n=408 participants at risk Extended Treatment: builds upon our current brief treatment and provides 12 additional weeks of nicotine replacement (24 weeks total) with individualized, counselor-delivered motivational and manualized cognitive behavioral cessation treatment.
Product Issues NRT side effect: Blister on tongue	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.24% 1/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Product Issues NRT side effect: Bloating of extremities (e.g. hands, legs)	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.25% 1/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Product Issues NRT side effect: Body ache	0.76% 1/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Product Issues NRT side effect: Bumps on tongue	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.25% 1/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Product Issues NRT side effect: Burning sensation	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	1.7% 7/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	1.2% 5/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Product Issues NRT side effect: Cold sweats	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.96% 4/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.98% 4/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Product Issues NRT side effect: Confusion	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.48% 2/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.49% 2/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Injury, poisoning and procedural complications Ankle injury	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.49% 2/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Cardiac disorders Chest pain	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.48% 2/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Cardiac disorders Heart palpitations	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.24% 1/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Surgical and medical procedures Diagnostic visits	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.48% 2/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Eye disorders Swollen eye	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.25% 1/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Injury, poisoning and procedural complications Fall Injury	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.25% 1/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Gastrointestinal disorders Gastrointestinal discomfort, pain, injuries	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.24% 1/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.25% 1/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Injury, poisoning and procedural complications Hand injury	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.25% 1/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Product Issues Medication side effect: Headache	0.76% 1/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Product Issues Medication management visit	0.76% 1/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Product Issues Medication refilll visit	0.76% 1/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.24% 1/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Product Issues Lightheadness from using both NRT and cigarette use	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.49% 2/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Product Issues NRT side effect: Discomfort	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.24% 1/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Product Issues NRT side effect: Agitation	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.24% 1/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.25% 1/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Product Issues NRT side effect: Allergy to patch	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.49% 2/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Product Issues NRT side effect: Anxiety	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.48% 2/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.49% 2/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Product Issues NRT side effect: Bit tongue when used nicotine gum	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.24% 1/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Product Issues NRT side effect: Coughing	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.49% 2/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Product Issues NRT side effect: Craving to smoke	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.25% 1/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Product Issues NRT side effect: Diminished ability to taste	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.25% 1/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Product Issues NRT side effect: Dizziness	1.5% 2/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	3.6% 15/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	3.2% 13/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Product Issues NRT side effect: Drowsiness	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.24% 1/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Product Issues NRT side effect: Dry mouth	0.76% 1/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.48% 2/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	1.2% 5/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Product Issues NRT side effect: Dry skin	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.25% 1/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Product Issues NRT side effect: Fainting	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.25% 1/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Product Issues NRT side effect: Fatigue	0.76% 1/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.24% 1/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Product Issues NRT side effect: Feeling on edge	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.24% 1/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Product Issues NRT side effect: Feeling paranoid	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.24% 1/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.00% 0/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Product Issues NRT side effect: Gastrointestinal distress	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.72% 3/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	1.5% 6/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Product Issues NRT side effect: Headache	0.76% 1/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	3.4% 14/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	3.9% 16/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Product Issues NRT side effect: Heart burn	0.76% 1/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.72% 3/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	0.74% 3/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Product Issues NRT side effect: Heart palpitations	0.00% 0/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	1.9% 8/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	2.0% 8/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.
Product Issues NRT side effect: Hiccups	0.76% 1/132 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	2.4% 10/416 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.	1.2% 5/408 • 18 months Participants assessed at 3, 6, 12 and 18 months for any AEs related to NRT use and for SAEs of hospitalization or ER presentation. Information on deaths were collected from family/friends/providers/etc.